- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01293591
Garlic Intake And Biomarkers Of Cancer Risk
June 1, 2017 updated by: Janet Novotny, USDA Beltsville Human Nutrition Research Center
This study is being done to study the healthful benefits of eating garlic.
Previous studies suggest that garlic may help prevent cancer.
The investigators are recruiting healthy volunteers to participate in a study to determine the ways in which eating garlic may reduce cancer risk.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A crossover design will be utilized with each participant completing each treatment phase; participants will be randomly assigned to a sequence of dietary treatments.
There will be a 17-day washout period in between diet periods.
Participants will consume a garlic-free diet for the first 10 days of each diet period.
The dietary treatments will be administered on day 11 of each diet period.
Dietary treatments will be incorporated into food as follows: 1) 5 g (0.175 oz.) of garlic mixed with 15 g margarine on top of 270 kcal white bread, served as breakfast, or 2) 15 g margarine on top of 270 kcal white bread, served as breakfast.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Beltsville, Maryland, United States, 20705
- USDA Beltsville Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 40-80 years
Exclusion Criteria:
- Younger than 40 years old or older than 80 years old
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)
- Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes.
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- Follicle stimulating hormone levels above 35 mIU/mL serum
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
- Use of any tobacco products in past 6 months
- Use of oral or IV antibiotics during the month preceding the study or during the study
- Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the study and during the study
- Known (self-reported) allergy or adverse reaction to garlic
- Inability to metabolize garlic
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
270 kcal White bread with 15 g margarine
|
Subjects will consume a garlic-free diet for 10 days.
On day 11, subjects will consume 270 kcal white bread with 15 g margarine.
|
Other: Garlic Treatment
270 kcal white bread with 15 g margarine and 5 g crushed garlic
|
Subjects will consume a garlic-free diet for 10 days.
On day 11, subjects will consume 270 kcal white bread with 15 g margarine and 5 g crushed garlic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Garlic metabolites
Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment
|
Garlic metabolites will be measured in blood and urine.
|
Day 11 of each treatment period -- before and 3 hours after treatment
|
Markers of gene expression
Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment
|
Lymphocyte microarray analysis, lymphocyte DNA genotyping.
Microarray results will be confirmed by RT-PCR.
|
Day 11 of each treatment period -- before and 3 hours after treatment
|
DNA damage
Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment
|
Comet assay, 8-oxo-dG, histone analysis
|
Day 11 of each treatment period -- before and 3 hours after treatment
|
Oxidative stress
Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment
|
Serum nitrate/nitrite, malondyaldehyde, glutathione, glutathione reductase, glutathione S-transferase, catalase, protein carbonyls, F2-isoprostanes.
|
Day 11 of each treatment period -- before and 3 hours after treatment
|
Biomarkers of inflammation
Time Frame: Day 11 of each treatment period -- before and 3 hours after treatment
|
C-reactive protein (CRP), vascular endothelial growth factor, IL-1, IL-6, TNF-α.
|
Day 11 of each treatment period -- before and 3 hours after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
February 8, 2011
First Submitted That Met QC Criteria
February 9, 2011
First Posted (Estimate)
February 10, 2011
Study Record Updates
Last Update Posted (Actual)
June 2, 2017
Last Update Submitted That Met QC Criteria
June 1, 2017
Last Verified
February 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- Garlic Study 2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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